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Randomised Study of Concomitant Radiochemotherapy in Non-small Cell Lung Cancer

NCT00633568 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2015-02-12

No results posted yet for this study

Summary

The purpose of the present trial is to assess if induction concurrent chemoradiotherapy followed by consolidation chemotherapy will improve survival in comparison with the same chemotherapy given as induction followed by consolidation concurrent chemoradiotherapy.

Conditions

  • Non-small Cell Lung Carcinoma

Interventions

DRUG

Concomitant Radiochemotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1

DRUG

Concomitant Chemoradiotherapy - Radiotherapy 66 Gy, Cisplatin, and Docetaxel

Concurrent chemoradiotherapy: Radiotherapy 66 Gy in 2 Gy/fraction, 5 fractions/wk (6.5 weeks)with Cisplatin 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy)and Docetaxel 20 mg/m²/week (6 times, beginning on day 1 of radiotherapy) Chemotherapy : Cisplatin 60 mg/m² and Docetaxel 75 mg/m² on day 1

Sponsors & Collaborators

  • European Lung Cancer Working Party

    lead OTHER

Principal Investigators

  • Thierry Berghmans, MD · European Lung Cancer Working Party

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • Belgium
  • France
  • Greece
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633568 on ClinicalTrials.gov